The Impact of Metformin on the Outcome of Gouty Arthritis in a Cohort of Egyptian Gouty Patients.

NCT05332795 | Completed DMC

• 1 other identifier: 1478
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To study the impact of metformin on the outcome of gouty arthritis in a cohort of Egyptian gouty patients, and to evaluate its effect on local joint inflammation, inflammatory cytokines (IL-1β and IL-6), and life quality. Methods: A prospective randomized, single-blinded parallel randomized control study included 100 patients with active inflammatory gouty arthritis were randomized to receive metformin (1000mg/day) or placebo in addition to the traditional lines of treatment of gout. The clinical and laboratory data of the patients will be analyze at baseline, then after 3, and 6 months, with the assessment of gout disease activity, in addition, serum IL-1β and IL-6, the number of attacks per year, treatment satisfaction, quality of life, and disability index were evaluated at the 6th month from starting metformin and placebo therapy.

Conditions

Gouty Arthritis

Outcome Measures

Primary Outcomes (3)

• Serological remission criteria

  by measuring serum uric acid for patients of the present study, it must be less than 6 mg/dL.

  at 3 months post intervention.

• Articular remission criteria

  by examining the number of swollen and tender joints score, they must be less than 2 tender and swollen joints..

  at 3 months post intervention.

• Clinical remission criteria

  by assessing the grade of joint pain, it must be reduced from the first visit(regarding Visual analogue scale

  at 3 months post intervention.

Secondary Outcomes (1)

• Gout Impact Scale (GIS)

  at 3 months post intervention.

Other Outcomes (1)

• Health-related quality of life HRQOL

  at 3 months post intervention.

Study Arms (2)

group 1: gouty patients on metformin.

ACTIVE COMPARATOR

metformin users: include gouty patients, who will receive metformin tablets (1000 mg) once daily for about 3 months.

Drug: Metformin

gouty patients on placebo.

PLACEBO COMPARATOR

placebo users: include gouty patients, who were on placebo tablets once daily for about 3 months.

Drug: Placebo

Interventions

Metformin DRUG

gouty patients, will receive metformin tablets (1000 mg) once daily for about 3 months.

group 1: gouty patients on metformin.

Placebo DRUG

gouty patients, will receive placebo tablets once daily for about 3 months.

gouty patients on placebo.

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• gouty patients who fulfilled the American College of Rheumatology clinical criteria.
• gouty patients with active inflammatory arthritis.

You may not qualify if:

• Patients with any type of inflammatory arthritis.
• Patients with systemic disease as diabetes, hypertension,
• Patients with hyperlipidemia, coronary artery disease,
• Patients with renal or hepatic insults,
• pregnant and lactating females

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Dalia Salah Saif

Menoufia Governorate, MD, 123455, Egypt

Location

MeSH Terms

Conditions

Arthritis, Gouty

Interventions

Metformin

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of physical medicine,rheumatology and rehabilitation.

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 18, 2022
• Study Start: June 28, 2022
• Primary Completion: December 31, 2023
• Study Completion: February 20, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

EG (1)